- AbbVie (North Chicago, IL)
- …technology, quality, regulatory/compliance requirements, budget and resources. *Multiple product development experiences of leading a CMC team through IND ... from various departments and divisions. Accountable for creating a CMC development plan in collaboration with line...needed. + Critically evaluates and integrates drug substance, drug product , and device inputs to CMC team… more
- Merck (Rahway, NJ)
- **Job Description** **Principal Scientist / Director , GLOBAL REGULATORY CMC Biologics (R5)** Under general supervision of an Executive Director /Senior ... is responsible for developing and implementing Chemistry, Manufacturing, and Controls ( CMC ) regulatory strategies for our organization's biologics product … more
- Bristol Myers Squibb (Princeton, NJ)
- …minds and ideas across the enterprise to drive strategic choices for Global Product Development and Supply. From candidate selection to commercial launch and ... alongside some of the brightest minds in biopharma. The Director , CMC Team Leader is responsible for...manufacturing processes with appropriate control strategies. + Represents the Product Development organization on R&D Project Teams… more
- Takeda Pharmaceuticals (Boston, MA)
- …Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...experience including experience as an RA CMC product lead with late stage development , international… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Implement global CMC regulatory strategies to enable life-cycle product /process development strategy while maintaining global licensure and right to ... in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is...and Skills** + Lead the execution and influence the development of global CMC regulatory strategies, including… more
- Takeda Pharmaceuticals (Boston, MA)
- …organization to think proactively and utilize science and risk based approach to product development and LCM activities. + Contribute to creating and ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA - CMC Pharmaceuticals- Small Molecule...Pharmaceuticals. **How you will contribute:** + Leads the Early Development Pharmaceuticals GRA CMC regulatory team in… more
- Amicus Therapeutics (Marlow, OK)
- Director , CMC RA Location Marlow, UK...Professional Work Experience Requirements + 10+ years' experience in CMC product development , regulatory. + ... Regulatory Affairs, Technical Operations, Science and Quality Assurance. + Ensure CMC development strategies are aligned with global regulatory expectations.… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC -...+ Serves as regulatory CMC representative on development and marketed product teams. + Responsible ... global programs from pre-approval or post-marketing. + Capability to interact with CMC technical experts regarding process development and analytical issues. +… more
- Lilly (Philadelphia, PA)
- …standards, and cost targets. + Collaborate with cross-functional team leaders, including development , CMC regulatory, manufacturing, and supply chain teams, to ... radiopharmaceutical development and manufacturing and incorporate them into the CMC strategy. + Mentor and develop team members, providing coaching and feedback… more
- AbbVie (North Chicago, IL)
- …and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, ... requests. + Represents CMC regulatory affairs on teams such as the product development , Global Regulatory Product Teams and Operations brand teams,… more
- AbbVie (North Chicago, IL)
- …respect to time and budget. + Serve as the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Develop standard ... the clinical/regulatory development strategy and provide drug development experience and advice to the CMC ...planning, preparation, review and approval of drug substance, drug product and analytical sections of CMC submission… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or to the governance bodies. **Responsibilities** - Accountability to lead teams within overall CMC development project(s), to support Sr CMC Lead. In case ... early and late phase drug development candidates within the team to support overall CMC development plan. - Represent CMC development project teams… more
- BeiGene (Emeryville, CA)
- …cell therapy development . Ideal candidate must be proficient in both CMC strategic planning, execution, and matrix team management. The successful applicant will ... cell therapies is a plus. + Broad understanding of all aspects of CMC including process development , regulatory and quality requirements, analytical … more
- Gilead Sciences, Inc. (Foster City, CA)
- …The Associate Director , Analytical Regulatory Science, collaborates with product development , manufacturing and quality teams on the construction, ... member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we… more
- Actalent (Boston, MA)
- …etc. * Collaborate with cross-functional teams to generate and refine the product development strategy. * Lead preparation of high-quality global clinical ... Key Duties & Accountabilities: * Actively represent Regulatory CMC and provide regulatory expertise as a member...development strategies. * Identify and clearly communicate regulatory CMC risks and opportunities to both the technical team… more
- Astellas Pharma (Westborough, MA)
- …and new initiatives in collaboration with local and global stakeholders. + Provides CMC regulatory expertise for New Product Planning and Licensing due diligence ... and/or credibility. **Organizational Context:** Reports to Director or Senior Director , Regulatory Affairs CMC . **Qualifications:** **Required** + BS in… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development , located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...small molecule pipeline. Your responsibilities will include driving the development and manufacturing of drug substances, overseeing both internal… more
- Merck (West Point, PA)
- …diseases. Our Company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development . Vaccine Drug Product ... key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development ...The Director will report to the Executive Director of Vaccine Drug Product Development… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …areas. + This role is accountable for delivering Excellence in leadership, Excellence in CMC Strategic Development , and the implementation of playing to win ... 13 years of experience **Technical Skills/Competencies:** + Experienced leader in drug development of commercially viable product across modality and therapeutic… more
- Takeda Pharmaceuticals (Boston, MA)
- …mass spectrometry, immunological and potency assays, ) + Contribute to product development from Pharmaceutical Sciences to Commercialization by collaborating ... within a cross-functional, cross-cultural global team structure + Knowledge and experience with product development and clinical supply processes and product … more